Insertion Depth of Left-sided Double-lumen Tube: a New Predictive Formula

Sponsor
Imam Abdulrahman Bin Faisal University (Other)
Overall Status
Completed
CT.gov ID
NCT04329416
Collaborator
King Saud University (Other)
65
1
1
10.3
6.3

Study Details

Study Description

Brief Summary

The authors developed a formula for predicting the accurate depth of DLT insertion into the appropriate bronchus based on height as follows [The predicted insertion depth of left DLT (cm) equals 0.249 × (BH)0.916] [R]. That pilot study showed comparable correlations between five formulae [Brodsky et al, Bahk and Oh R, Takita et al, Chow et al, Lin]. However, that formula developed has not been validated yet.

We hypothesized that previously published formula would predict the accurate depth of left-sided DLT insertion. We aimed to investigate the efficacy of this formula to estimate the optimum insertion depth of the DLT using a flexible bronchoscope and decrease the incidence of DLT displacement into the appropriate bronchus, the need for bronchoscopic adjustment, and complications including soreness of throat and mucosal injury.

Condition or Disease Intervention/Treatment Phase
  • Other: Predicted depth of insertion
  • Other: Optimized depth of insertion
  • Other: Adjustment of depth of insertion
N/A

Detailed Description

Accurate placement of the double-lumen tube [DLT], the commonly used tool to provide one-lung ventilation during thoracic surgery, is a real challenge for the thoracic anesthesiologists. Optimal DLT depth, defined as the blue endobronchial cuff below the carina, would decrease the incidence of obstructing the trachea and the contralateral bronchus (Brodsky). Additionally, deep insertion of the bronchial cuff of the DLT would obstruct the upper lobe bronchus (Brodsky). The careful adjustment of the depth and optimal positioning of the DLT using a flexible fiberoptic bronchoscope need a skilled anesthesiologist to reduce the time to DLT intubation. (Charles D. Boucek et al)

There are several methods have been described to predict the proper depth of DLT insertion. Chow et al. documented the validity of the developed formula based on the clavicular-to-carinal distance of trachea and height in 78% of patients studied. Brodsky et al. demonstrated that a height-and-gender-based formula could predict the depth of DLT insertion. Liu et al. reported an accurate depth of DLT insertion in 90% of patients studied measuring the distance between the vocal cord and carina according to the chest CT.

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A prospective observational single-center open-label studyA prospective observational single-center open-label study
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Efficacy of Height-Based Formula to Predict Insertion Depth of Left-Sided Double Lumen Tube. A Prospective Observational Study
Actual Study Start Date :
May 7, 2019
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Predicted depth of insertion

The predicted insertion depth of the DLT was calculated using the formula [0.249 x (BH) 0.916] before induction of anesthesia using an application on the smartphone

Other: Predicted depth of insertion
A left-sided double-lumen tube was introduced beyond the vocal cords when the train-of-four stimulation of the ulnar nerve revealed 1 or 2 twitches, the stylet was removed, the double-lumen tube was rotated 90° counterclockwise and then advanced blindly to the predicted depth of insertion.

Other: Optimized depth of insertion
The optimal position of the double-lumen tube, defined as the inflated endobronchial cuff is placed in the left main bronchus just below the carina without herniation, which was confirmed using a flexible bronchoscope in both supine and lateral decubitus positions.

Other: Adjustment of depth of insertion
If the endobronchial cuff was placed too deeply or too proximal, subsequently, the double-lumen tube was withdrawn or advanced, respectively, using the flexible bronchoscope until the optimum position of the double-lumen tube was achieved.

Outcome Measures

Primary Outcome Measures

  1. The rate of optimum position of the double-lumen tube [for 15 minutes after double-lumen tube insertion]

    The rate of optimum position of a left-sided DLT without further adjustments, defined as the inflated endobronchial cuff is placed in the left main bronchus just below the carina without herniation

Secondary Outcome Measures

  1. The calculated predicted depth of insertion [immediately before induction of general anesthesia]

    The predicted insertion depth of the DLT was calculated using the formula [0.249 x (BH) 0.916] using an application an application on the smart phone

  2. The initial depth of insertion [for 15 minutes after double-lumen tube insertion]

    The "initial depth of insertion," was measured using the external centimeter markings on the DLT's lumen at the level of incisors

  3. Position of the double-lumen tube with the flexible bronchoscope [for 15 minutes after double-lumen tube insertion]

    The position of the DLT with the flexible bronchoscope would be rated either (1) optimally placed, (2) too far out, or (3) too far in

  4. The need for bronchoscopic adjustments [for 15 minutes after double-lumen tube insertion]

    If the endobronchial cuff was placed too deeply or too proximal, subsequently, the DLT was withdrawn or advanced, respectively, using the flexible bronchoscope until the optimum position of the DLT was achieved. The optimizing maneuvers were recorded

  5. The final correct depth of insertion [for 15 minutes after double-lumen tube insertion]

    the "final correct depth of insertion", defined as the distance from the distal opening of the bronchial lumen to the corner of the mouth, was measured with a flexible bronchoscope passing through the bronchial lume

  6. Time to final correct double-lumen tube positioning [for 25 minutes after double-lumen tube insertion]

    Time to final correct DLT positioning from time of laryngoscopy was recorded

  7. Changes in heart rate [for 25 minutes after double-lumen tube insertion]

    Postintubation changes in heart rate was recorded

  8. Changes in mean arterial blood pressure [for 25 minutes after double-lumen tube insertion]

    Postintubation changes in mean arterial blood pressure was recorded

  9. Changes in peripheral oxygen saturation [for 25 minutes after double-lumen tube insertion]

    Postintubation changes in peripheral oxygen saturation was recorded

  10. Degree of lung collapse [for 30 minutes after start of surgery]

    degree of lung collapse was rated as excellent, good, poor, or very poor

  11. The incidence of soreness of throat [for 24 hours after start of surgery]

    Patients were asked about the occurrence and severity of postoperative sore throat

  12. The incidence of mucosal injury [for 40 minutes after double-lumen tube insertion]

    The incidence of mucosal injury using the flexible bronchoscope was reported after intubation using the double-lumen tube

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Underwent thoracic surgery

  • Using a left-sided double-lumen tube for one-lung ventilation

Exclusion Criteria:
  • Anticipated or known difficult airway

  • Refuse to sign the consent

  • Withdraw the consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 King Saud University Riyadh Saudi Arabia 11472

Sponsors and Collaborators

  • Imam Abdulrahman Bin Faisal University
  • King Saud University

Investigators

  • Study Chair: Abdelazeem A Eldawlatly, MD, Professor of Anesthesia, College of Medicine, King Saud University
  • Study Director: Mohamed R El Tahan, MD, Associate Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care, Imam Abdulrahman Bin Faisal University (formerly, University of Dammam), Dammam, Saudi Arabia,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier:
NCT04329416
Other Study ID Numbers:
  • E-18-3064
First Posted:
Apr 1, 2020
Last Update Posted:
Apr 1, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 1, 2020